5.2.7 Open the door from
non-aseptic side by pressing door open button.

5.2.8 Prepare the required
materials and pack the materials in sterilization reels for laboratory glassware and accessories, in Dacron bags for garments and with cotton plugs or
caps as appropriate for media containers.

5.2.9 Label each pack of
laboratory glassware, accessories and garments with a strip of chemical
indicator tape and write the date of sterilization and use before date. For
media containers label as per SOP for media preparation.

5.2.10 Put the required material
on the shelves of the chamber as per validated load patterns and quantity
loaded should conform between minimum and maximum validated load patterns. When
the load is in between the minimum and maximum load patterns, load as per
maximum load pattern. Enter the load details in appropriate
annexures.

5.2.11 Place chemical indicator
on at least one of the article to be sterilized / or in sterilization pouch,
for every cycle other than Bowie-dick and Vacuum leak test.

5.2.12 Close the door by pressing
close button.

5.2.13 Put Auto-Off-Manual key
switch in Auto mode.

5.2.14 Switch on the dot-matrix
printer and strip chart recorder and ensure the papers are properly loaded.

5.2.15 Enter the cycle details,
run number; load details and sterilization hold times in the Autoclave Log
Sheet and appropriate Autoclave Load Details format. Run number shall be allotted to each cycle starting
from 01 every day.

5.2.16 Select the desired set
parameters that are fed in Programmable Logical Control (PLC) as per validation
summary report and run the cycle.

5.2.17 After completion of cycle,
unlock the key. Open the door from aseptic side by pressing “Door Open’ button.

5.2.18 Remove the load from the
shelves.

5.2.19 Close the door by pressing
“Door Close’ button and lock the key.

5.2.20 Post sterilization, write
the run number on chemical indicator, sign and attach to Autoclave Load Details
reporting format.

5.3 Operation of Programmable
Logical Control (PLC).

5.3.1 Press
F4 Key in the PLC keypad, “Menu 1’ will appear, with following options:

5.7 Standard
(STD) Process

5.7.1 Standard
cycle should be operated after completion of Vacuum Leak Test and Bowie – Dick
Test (Whenever Applicable) and this cycle is used for sterilization of culture media and diluents.

5.7.2 Place
the load as per load configuration and operate the cycle as per 5.2 by
selecting ‘Standard Process’.

5.8 Sterilization
and Replacement of Air In-Line Filter

5.8.1 Air
In-Line Filter should be with a sterilized once in every two weeks.

5.8.2 Sterilization:
Pack the filter in sterilization reels and place in autoclave and sterilize
using HPHV1 Process.

5.8.3 Replacement:
Open the stainless steel filter housing and remove the filter and replace with a previously
sterilized filter.

5.8.4 Integrity
Test: Perform Integrity test/bubble point test of filters before replacement
and after removal from the housing. It should conform the specifications as per
manufacturer’s instructions.

5.8.5 Sterilization
of filters should not exceed the number of cycles mentioned in the filter
manufacturer’s CoA.

5.9 Alarms
acknowledgement procedure

5.9.1 When
an alarm occurs, press F4 key for main menu, then press F3 key for Menu 2.

5.9.3 F1
(Alarm screen) and F4 (Main screen) will appear on the screen.

5.9.4 Press
F1 (Alarm screen) then press the down arrow ▼ key to scroll the screen.

5.9.5 F1
(Acknowledge) and F4 (Process data) will appear on the screen.

5.9.6 Press
the F1 key to acknowledge the alarm.

5.10 Strip
Chart Recording and Reading

5.10.1 When
printing the cycle parameters through PLC, simultaneously start the strip chart
by pressing ‘Function” button once and ‘Enter’ Button twice. This will print
the current values of all sensors.

5.10.2 To
start recording of cycle on strip chart, press ‘Red’ Button when the autoclave
cycle starts and after completion of cycle again ‘Red’ Button to stop
recording.

5.10.3 The
Strip Chart should be read horizontally for time and vertically for values.
Settings of the Strip Chart as follows: